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Hyperhidrosis, Developing a Treatment Approach Aims 1 & 2

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ClinicalTrials.gov Identifier: NCT03416348
Recruitment Status : Recruiting
First Posted : January 31, 2018
Last Update Posted : October 24, 2018
Sponsor:
Collaborators:
US Department of Veterans Affairs
U.S. Army Medical Research and Development Command
Information provided by (Responsible Party):
Colby Hansen, University of Utah

Brief Summary:

The objective is to establish an evidence base for a hyperhidrosis treatment algorithm in amputees. This project will address a problem that has troubled Service members, Veterans, and civilians with amputations for decades, impacting satisfaction with prosthetic use, residual limb skin health, and negatively affecting quality of life. Prior research in this area has been limited and insufficient. The Investigators are confident that improving the evaluation and treatment of residual limb hyperhidrosis will reduce the secondary health consequences of amputation and will lead to improved quality of life. This will be accomplish by completing the following specific aims.

Aim 1: Test the validity of the Minor iodine-starch test in amputees. Hypothesis: The iodine-starch test is a valid diagnostic tool of hyperhidrosis and can be useful for the identification of focal areas of sweating on a residual limb Aim 2: Test the effectiveness of a prescription strength topical antiperspirant (Aluminum Chloride 20%) on hyperhidrosis of the residual limb.

Hypothesis: Aluminum Chloride will be more effective at controlling sweating than placebo


Condition or disease Intervention/treatment Phase
Hyperhidrosis Drug: Aluminum Chloride 20% (deodorant) Drug: Alcohol Phase 1

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Intervention Model Description: For the two aims of the study, subjects will be recruited from the amputee clinics held at the Salt Lake VA Medical Center or the University of Utah. Combined, these clinics serve approximately 500 patients and see approximately 75 new patients each year. Based on the investigators work, which showed 66% of patients with HDSS scores of 2 or greater, we will have a potential pool of up to 330 eligible patients for the studies that follow. We expect to enroll approximate equal numbers from both sites for each of the aims of this study.
Masking: Double (Participant, Investigator)
Masking Description: For Aim 1 there will be no masking. Aim 2, recruitment methods will be by convenience sampling. Subjects in Aim 1 reporting an HDSS of 2 or greater and additional subjects as needed from the U of U or VA clinics with HDSS of 2 or greater will be invited to participate in this crossover study. Subjects will be randomized equally to two sequence arms by a random number generator. The first arm will receive in sequential order every 3 weeks: Aluminum Chloride, a placebo of ethyl alcohol base, Aluminum Chloride, and placebo. The second arm will receive in sequential order every 3 weeks: placebo, Aluminum Chloride, placebo, and Aluminum Chloride. Each condition will last for 3 weeks, which will allow enough time for the Aluminum Chloride and placebo to demonstrate their respective effects. The first week of each period will also serve as a sufficient washout for the previous period. The total trial length, then, will be 12 weeks.
Primary Purpose: Treatment
Official Title: Hyperhidrosis of the Residual Limb in Patients With Amputations: Developing a Treatment Approach, Aims 1 and Aim 2
Actual Study Start Date : May 8, 2018
Estimated Primary Completion Date : October 15, 2020
Estimated Study Completion Date : October 15, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Sweat

Arm Intervention/treatment
Placebo Comparator: Placebo Comparator AIM 1
Aim 1: Demonstration of a strong association of the Sweating Intensity Visual Scale (SIVS) score with the HDSS would provide validation for use of the SIVS in interpreting the iodine-starch test and would establish the value of the iodine-starch test in clinical practice guidelines for diagnosing hyperhidrosis in amputees, just as it is in dermatology practice.
Drug: Aluminum Chloride 20% (deodorant)
Aluminum Chloride (deodorant)
Other Name: Drysol, XeracAC

Drug: Alcohol
Placebo
Other Name: Ethyl Alcohol

Active Comparator: Aluminum Chloride vs Placebo in Amputees
Aim 2: The investigators will have completed the first clinical trial of Aluminum Chloride for residual limb hyperhidrosis. The investigators will then have a solid foundation of data that demonstrates the rates of adverse effects such as skin irritation, and rates and magnitudes of improvement in subjective and objective measures of sweating.
Drug: Aluminum Chloride 20% (deodorant)
Aluminum Chloride (deodorant)
Other Name: Drysol, XeracAC

Drug: Alcohol
Placebo
Other Name: Ethyl Alcohol




Primary Outcome Measures :
  1. Hyperhidrosis Disease Severity Scale (HDSS) [ Time Frame: 1 day ]
    The outcome measure of Aim 1 will be measuring the Hyperhidrosis Disease Severity Scale (HDSS). The HDSS is scored on a number scale of 1-4. Score range from 1 (lowest) demonstrating sweating (hyperhidrosis) is least noticeable and does not interfere with daily activities (least impactful) to 4 (highest) sweating is intolerable and interferes significantly with daily activities. This measurement will be completed in a single site visit.


Secondary Outcome Measures :
  1. Hyperhidrosis Disease Severity Scale (HDSS) [ Time Frame: 12 weeks ]
    The outcome measure of Aim 2 will be measuring the Hyperhidrosis Disease Severity Scale (HDSS) in a cross over design at 12 weeks of those participants with an HDSS score of 2 or higher. The HDSS is scored on a number scale of 1-4. Score range from 1 (lowest) demonstrating sweating (hyperhidrosis) is least noticeable and does not interfere with daily activities (least impactful) to 4 (highest) sweating is intolerable and interferes significantly with daily activities.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Aim 1 and Aim 2

Inclusion Criteria:

  • Provision of signed and dated informed consent form (ICF)
  • Stated willingness to comply with all study procedures and availability for the duration of the study
  • Male or female, age 18 or older
  • Have a prosthetic device
  • In good general health as evidenced by medical history
  • If subject is currently using aluminum chloride participant must be discontinued for at least one week prior to participation in the study.

Exclusion Criteria:

  • Open sores or wounds on the residual limb
  • Known sensitivity or allergy to iodine
  • Known sensitivity to antiperspirant, aluminum chloride hexahydrate

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03416348


Contacts
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Contact: Heidi Hansen 801.585.2373 heidi.hansen@hsc.utah.edu
Contact: Jacob Smith 801.585.6998 jacob.smith@hsc.utah.edu

Locations
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United States, Utah
George E. Wahlen Department of Veterans Affairs Medical Center Not yet recruiting
Salt Lake City, Utah, United States, 84132-2101
Contact: Heidi Hansen    801-913-1955    heidi.hansen@hsc.utah.edu   
Contact: Jacob Smith    801.585.6998    jacob.smith@hsc.utah.edu   
Sub-Investigator: Bradeigh Godfrey, MD         
University of Utah Recruiting
Salt Lake City, Utah, United States, 84132-2101
Contact: Heidi Hansen    801-585-2373    heidi.hansen@hsc.utah.edu   
Contact: Jacob Smith    801.585.6998    jacob.smith@hsc.utah.edu   
Principal Investigator: Colby Hansen, MD         
Sponsors and Collaborators
Colby Hansen
US Department of Veterans Affairs
U.S. Army Medical Research and Development Command
Investigators
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Principal Investigator: Colby Hansen, MD University of Utah

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Responsible Party: Colby Hansen, Principle Investigator, University of Utah
ClinicalTrials.gov Identifier: NCT03416348     History of Changes
Other Study ID Numbers: OP150030 (Aim 1&2)
OP150030 ( Other Grant/Funding Number: DOD )
First Posted: January 31, 2018    Key Record Dates
Last Update Posted: October 24, 2018
Last Verified: October 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Colby Hansen, University of Utah:
amputation
amputations
sweating
residual limb
service members
civilians

Additional relevant MeSH terms:
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Hyperhidrosis
Sweat Gland Diseases
Skin Diseases
Ethanol
Anti-Infective Agents, Local
Anti-Infective Agents
Central Nervous System Depressants
Physiological Effects of Drugs